The present invention relates to liquid formulations of pharmaceutically active compounds. In particular, the invention relates to liquid formulations prepared by admixing a liquid with a powdered composition. The resulting liquid formulation is a stable solution or dispersion in which the protein is bound to the pharmaceutically active compound. The protein can be full length or various hydrolyzed fragments thereof. Also provided herein are methods for preparing the powdered composition, as well as kits for preparing the liquid formulation.
Though only encompassing about 13% of the general population, elderly patients account for around 33% of all prescribed medications. The average ambulatory senior takes almost six medications simultaneously, while a nursing home patient may take seven to ten medications. In general, a larger pill (e.g., a capsule, a gel cap, or a tablet) results in greater difficulty in swallowing the medication. For the elderly, swallowing medications can be difficult or painful, a condition commonly referred to as dysphagia, which can lead to low compliance by the patient. Dysphagia is also associated with several chronic diseases, including neurodegenerative diseases (e.g., Alzheimer's disease, Parkinson's disease, etc.), psychiatric diseases, metabolic diseases, and endocrine diseases. It can also be a problem for patients receiving radiation or chemotherapy.
For patients suffering from dysphagia who are on medication, it is common practice for the patient or healthcare professional to crush the medication and mix it into a favorite liquid or soft food, such as applesauce, for consistency and taste masking. In some instances, multiple medications may be crushed and then mixed together within the patient's food or drink. While compliance may be increased by this practice, dose strength, drug stability, and pharmacokinetics are compromised, adversely affecting the efficacy of the medication.
Liquid formulations have been widely used for pediatric medications to provide for easier administration. These formulations are well known in the art and are exemplified by, for example, various antibiotics, such as amoxicillin, augmentin, and gatifloxacin; antiasthmatics, such as zafirlukast (Accolate®); and antivirals, such as zidovudine, lamivudine, stavudine, and abacavir. By contrast, little systematic effort has been made to develop liquid formulations for geriatric patients or other adult patients with swallowing difficulties. In practice, a compounding pharmacist may attempt to make a liquid formulation for an older patient, but no consistent and reliable method has been developed for all drug products.
The above-mentioned problems lead to sub-optimal and/or erratic dosing, which may affect disease progression and lead to an increase in long term health care. Thus, there is a need for stable and effective liquid formulations for delivering a variety of pharmaceutical agents.